Among background art includes U.S. Pat. No. 4,840,187 of Brazier which describes a rigid, cylindrical tubular container to dispense rigid male urine collection sleeve, not a flattened closed container openable by pressing upon the side edges corresponding to the major axis of the open end of the container, as noted in the present invention.
The use of the flattened, openable container in the present invention would be discouraged, if not clearly taught away from the rigid cylindrical tubular container of Brazier '187.
Brazier '187 discloses a sheath applicator for directing a steam of urine. Thus the single sheath is open at the distal end and not closed as in a condom. In addition, the tubular casing does not conform to the shape of a condom, has a flexible liner casing which is exposed by side openings to permit adjustment of the flexible liner casing on the penis. Strip 12 therein is designed to expose an adhesive so when the sheath is rolled over the penis, the end of the sheath can be cemented to the base of the penis.
U.S. Pat. No. 4,696,095 of Elenteny has peel away multi-layered gloves which are peeled away one at a time. This arrangement is not suitable for use as a condom, as it lacks the leak proof layers in between the various layers of gloves.
Various devices have been made for releasing a single glove from a vacuum chamber. U.S. Pat. No. 5,269,405 of the Applicant describes a package for dispensing one or more gloves from a nested plurality of gloves, wherein a pump creates a vacuum to inflate the gloves in an open expanded state.
Applicant's U.S. Pat. No. 5,269,405 also discloses a container for sequentially dispensing a single glove from a plurality of gloves placed inside each other, wherein a vacuum holds the plurality of gloves intact in an open position for insertion of a hand therein.
Wood '405 discloses a dispenser for gloves which are stored in a layered condition within a container and a vacuum is applied. Each glove can be removed without disturbing the vacuum. Each glove has the open end pulled around the outside of the container with each succeeding glove layered on top of the preceding one.
Adhesive is employed to maintain a seal. To remove a glove the open edge of the glove is pulled away thereby relieving the vacuum surrounding the glove. The glove is pulled away thereby relieving the vacuum surrounding the glove to be removed, thus easing the removal of the glove. This is a far different arrangement from the present invention.
Applicant's U.S. Pat. No. 5,456,354 describes a package dispenser for garments such as one or more gloves or condoms, from a dispenser which is shaped like the garment to be dispensed. Among or other patents are U.S. Pat. Nos. 3,695,493 of Karr, disclosing an apparatus for alternately donning and removing a single glove within a vacuum chamber 4,069,913 of Harrigan for a package for donning a single surgical glove, and 4,889,266 of Wight for an apparatus which removes a single glove from a disposable single use package.
Other related patents include U.S. Pat. No. 685,574 of Conboie which shows a hand-shaped case, but for an unrelated use in mortuaries. The U.S. Pat. No. 1,938,685 to Breulis shows a somewhat bulb-shaped cavity for applying a surgical glove. The cuff of the glove is stretched over the opening of the cavity. The U.S. Pat. No. 2,741,410 to Violette shows a rack for removing gloves that may be wall mounted.
The U.S. Pat. No. 2,886,824 to Smith shows a rubber glove having a tapered wrist shape. The U.S. Pat. No. 3,852,826 to Schindler shows a surgical glove which is sterilized using radiation. The U.S. Pat. No. 4,186,445 to Stager shows a glove having a mylar outer coating and a polymer foam inner coating. The U.S. Pat. No. 4,310,928 to Joung and U.S. Pat. No. 4,851,266 to Momose show talc free surgical gloves. The U.S. Pat. No. 4,696,065 to Elenteny shows a single peel-away multi-layer glove. No powder is used between the layers. This glove has a slight taper at the wrist portion.
The U.S. Pat. No. to Richardson, 5,224,221 describes a single glove which is two layers, one inside the other, with the space between them evacuated.
Various devices have been made for packaging condoms. U.S. Pat. No. 5,269,405 of the Applicant herein describes a package for a plurality of condoms, wherein the condoms are nested within a tubular package having an open end and a closed end, wherein a pump creates a vacuum to inflate the condoms in an open inflated state. Applicant's U.S. Pat. No. 5,456,354, noted above, describes a package for a plurality of condoms which specifically describes a removable layer between each of the condoms, to maintain each of the condoms sanitary before use.
Among prior art patents related to condom manufacturing are U.S. Pat. No. 5,136,825 of White for an apparatus and method for compacting condoms in a pleated package and U.S. Pat. No. 4, 867,176 of Lash for a vacuum formed package for a female condom, as shown in FIG. 16 therein.
U.S. Pat. No. 4,638,790 of Conway describes a rolled condom which is adhesively adhered to the skin of a male user.
U.S. Pat. No. 5,316,019 of Jones described an annular applicator which functions as a package for a condom.
U.S. Pat. No. 5,267,575 of Hrisko describes a dispenser for an individual condom, wherein the condom is inflated before each use by blowing air through the dispenser to inflate the condom before donning. However, Hrisko '575 only describes an applicator for single condom, which must be inflated by the user blowing air into the dispenser before each use.
U.S. Pat. No. 4,987,905 of Broad describes a "no hands" application for a condom, wherein a pair of strips are moved to release the condom.
However, none of the above patents for donning condoms disclose an apparatus for donning one of a plurality of hermetically sealed condoms within a condom shaped chamber. As defined in the Academic Press Dictionary of Science and Technology, Publishers, ed. C. Morris, 1992 edition, at page 1015, a "hermetic seal" is defined as a seal that is impervious to air and other fluids, i.e. made airtight.
The United States Department of Health, Food and Drug Administration (FDA) mandates that condoms be manufactured to prevent pregnancy and to prevent the transmission of sexually transmitted diseases (STD's), from the mixture of bodily fluids between sexually active persons.
Pursuant to Title 21 U. S. Code, Section 360(c) (a) (1), FDA regulations classify medical devices in a hierarchy of classification standards, namely, Class I for medical devices which require general controls in manufacturing, Class II for medical devices which also require performance tests, and Class III, for medical devices which require FDA pre-market approval.
The FDA has classified the condom as a Class II device under 21 CFR 884.5300. The condom must be subject to rigorous performance tests, such as air burst tests, to certify that the condoms are sealed from leakage.
The FDA utilizes the manufacturer's standards of the American Society for Testing Materials (ASTM) entitled "Standard Specification for Rubber Contraceptives" (Condoms).sup.11 --Designation: D 3492-83 for quality control of leakage defects, wherein the acceptable quality level for leakage is 0.4 percent, that is, not to exceed 4 leaking condoms per 1000 is tested. The FDA's sampling inspections, pursuant to 21 CFR 800.20, are based on the tables of MIL - STD - 105 E which is the military sampling standards in "Sampling Procedure and Tables for Inspection by Attributes", dated May 10, 1989.
Among the tests for condoms include the Air Inflation Test, adopted in 1994 by U. S. inspectors, which includes inflating condoms, checking their elasticity, whereby experts determine the quality that keeps a condom intact during intercourse.
As noted in "How Reliable Are Condoms?" Consumer Reports, May 1995, pp 320-324, latex condoms are produced by dipping a cylindrical form in liquid latex and heating it. Machines shape and trim the condoms ring; then new condoms are washed and aged for a number of days, during a "curing" that lets the rubber complete the chemical actions that strengthen the latex. The final steps are rolling and wrapping individual condoms.
Industry standards require a width of no greater than 54 millimeters,--about 21/8 inches, to prevent slippage. The minimum length is 160 mm, roughly 61/3 inches.
Since 1987, the U.S. Food and Drug Administration has allowed condom boxes to list all the diseases condoms help avert.. More recently, the FDA advised a condom manufacturing company that because the disease-prevention message is so important, manufacturers should also print a disease prevention message on the wrappers of individual condoms.
Therefore, both manufacturers and the FDA take steps to catch the flawed condoms before they can leave the factory.